Surgical kit for repairing leaks in fluid carrying vessels and organs and method thereof

ABSTRACT

A surgical kit for percutaneously repairing post-operative leaks in internal fluid carrying vessels and organs. The kit includes at least one syringe and at least one marker for placement on the body of the patient to mark the location of the leak. The syringe and marker are enclosed in a sterile package which includes a top cover and a bottom cover. A method for repairing a leak in a fluid carrying vessel or organ, such as the dura mater of the spinal cord, is also disclosed.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to a surgical kit for repairingleaks in fluid carrying vessels and organs, and in particular, to asurgical kit for percutaneously repairing post-operative cerebrospinalfluid leaks associated with intraoperative rents of the dura mater ofthe spinal cord.

[0003] 2. Description of the Related Art

[0004] Surgical procedures involving fluid carrying vessels and organshave risks associated with them that can extend beyond the actualsurgery itself. Once the actual surgery is complete, the patient must beclosely monitored to ensure that leaks at the surgical site do notdevelop. With the advent of many popular minimally invasive surgicalprocedures, such as laparoscopy, the vast benefits associated with theminimally invasive procedure may be lost if the patient must return tothe operating room to close leaks that develop in fluid carryingvessels, particularly if the leak must be closed using traditional opensurgical techniques.

[0005] Post-operative leaks are of particular concern followingneurosurgical procedures. The human spine is comprised of the spinalcolumn, having many vertebra which support the body and protect thedelicate spinal cord. The vertebra are generally of pentagon shape, withthe spinal processes (or “points”) extending posteriorly to thepatient's back. The vertebra are separated and cushioned from each otherby the discs, which act as pads between the vertebra to permit movementand shock absorption for the spine. The center of the vertebra arehollow, to permit the spinal cord to extend from the base of the spineto join with the medulla oblongata of the brain. Nerves extend outwardlyfrom the spinal cord between the vertebra. The brain and the spinal corditself are covered with three main layers: the pia mater, the arachnoidmembrane, and the dura mater. The pia mater is a generally thin vascularmembrane which is covered by the arachnoid membrane. The arachnoidmembrane is in turn covered by the dura mater, which is a tough fibrousmembrane that contains and provides a passageway for the cerebrospinalfluid (CSF) to flow. Following neurosurgery, the patient is closelymonitored to determine if a rent in the dura mater has developed, whichcan have deleterious effects on the patient.

[0006] In the prior art, once a dural rent is identified, it is commonto place a spinal drain at the site and the patient is placed in theTrendelenburg position, with his head positioned below the feet at abouta 30-40 degree angle, with the knees bent. Typically, this will solvethe problem; however, if the leak is not sealed, oftentimes surgery isnecessary to close the rent and prevent further leakage of the CSF. Thisof course is traumatic to the recovering patient.

[0007] A need, therefore, exists for a kit having the instrumentsrequired for performing percutaneous procedures to repair leaks in fluidcarrying vessels and organs without requiring the patient to undergo atraditional surgical procedure to repair the vessel or organ. Aminimally invasive surgical technique is also needed to repair fluidleaks, such CSF leaks in the spinal cord, that may be accomplishedquickly and efficiently, to reduce the recovery time of the patient andto minimize the trauma associated with such repair procedures.

SUMMARY OF THE INVENTION

[0008] It is, therefore, an object of the present invention to provide asurgical kit to facilitate the percutaneous repair of leaks in internalfluid carrying vessels and organs.

[0009] It is also an object of the present invention to provide asurgical kit for repairing post-operative CSF leaks in the dura materfollowing neurosurgery in a minimally invasive manner.

[0010] It is yet another object of the present invention to provide aminimally invasive method for repairing leaks in internal fluid carryingvessels and organs, particularly CSF leaks in the dura mater of thespinal cord.

[0011] The above and other objects are achieved by providing a surgicalkit for repairing leaks in fluid carrying vessels and organs whichincludes a syringe and at least one marker in a sterile package, thesyringe for containing fibrin glue for sealing the leak and the at leastone marker for placement on the body of the patient to mark the locationof the leak.

[0012] In a preferred embodiment, the kit includes the syringe and atleast one marker, and a package for containing the syringe and marker,where the package includes a top cover and a bottom cover for enclosingthe syringe and marker. In another embodiment, the kit includes asyringe, a container carrying a bio-compatible fluid such as a fibringlue, at least one marker, and a package having a top cover and a bottomcover for containing the syringe, container and marker. In anotherembodiment, the kit includes a syringe filled with a fluid such as afibrin glue for sealing the leak, at least one marker, and a packageincluding a top cover and a bottom cover for containing the syringe andmarker. Preferably, the marker is adhesive-backed for maintaining itsplacement location on the body of the patient, and includes a hole inits center through which the needle of the syringe may pass, to guidethe needle to the location of the leak. In addition, it is preferredthat the syringe have calibrations or graduations on outer surface toenable the physician to gauge the depth of penetration of the needle toensure accurate placement of the needle with respect to the leak site.The kit may also be provided with other items that will assist in therepair procedure, such as a container, or even a second syringe,containing a contrast agent to facilitate locating the leak underradiographic or magnetic imaging, such as fluoroscopy, CT scan andmagnetic resonance imaging (MRI). A dual chamber syringe, a dual lumenneedle attached to the syringe, and even two syringes each carrying theseparate components of the fibrin glue are also contemplated. Sterilesurgical drapes may also be included.

[0013] A method for repairing leaks in internal fluid carrying vesselsand organs is also provided, which is minimally invasive and includesthe steps of determining the location of the leak, placing a marker onthe patient's body to mark the location of the leak, providing a syringeand a fibrin glue material, inserting the needle through a guide hole inthe marker into the patient's body to a location adjacent the leak, anddelivering the fibrin glue to seal the leak. It is contemplated that themethod be performed under radiographic or magnetic imaging to confirmthe accuracy of the location of the leak, the accuracy of the placementof the marker and the needle with respect to the leak site, and theaccuracy of the delivery of the fibrin glue.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The above and other objects, features and advantages of thepresent invention will become more readily apparent from the followingdetailed description of the preferred embodiments, taken in conjunctionwith the accompanying drawings, in which:

[0015]FIG. 1 illustrates a surgical kit for repairing leaks in fluidcarrying vessels and organs according to a first embodiment of thepresent invention;

[0016]FIG. 2 illustrates a second embodiment of the surgical kit of thepresent invention;

[0017]FIG. 3 illustrates a third embodiment of the surgical kit of thepresent invention;

[0018]FIG. 4 illustrates a fourth embodiment of the surgical kit of thepresent invention;

[0019]FIG. 5 illustrates a fifth embodiment of the surgical kit of thepresent invention;

[0020]FIG. 6 illustrates a sixth embodiment of the surgical kit of thepresent invention;

[0021]FIG. 7 illustrates a marker of the present invention, forplacement on the patient's body to mark the location of the leak in afluid carrying vessel or organ;

[0022]FIG. 8 illustrates an exploded perspective view of the surgicalkit of FIG. 1; and

[0023]FIG. 9 is a flow chart of the method of repairing a leak in fluidcarrying vessels and organs of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] Referring now to the drawings, in which like reference numeralsidentify similar or identical elements throughout the several views, andin particular to FIG. 1, there is shown a surgical kit 100 for repairingleaks in fluid carrying vessels and organs according to the presentinvention. Surgical kit 100 includes a syringe 106 and a plurality ofmarkers 108 for use in repairing leaks in internal vessels and organs,as will be described below. Syringe 106 preferably includes markings orgraduations on its needle, to assist the physician in locating thedistal tip of the needle with respect to the leak site inside thepatient's body. The syringe 106 may be pre-filled with a bio-compatiblefibrin glue material for delivery to the breach or rent in the wall ofthe vessel or organ, or may be provided empty for filling by thephysician during the repair procedure. Referring also to FIG. 8, the kit100 includes package 101, which consists of top cover 102 and bottomcover 104, which enclose and house the syringe 106 and the plurality ofmarkers 108. Preferably, top cover 102 is a molded plastic cover, withspaces for the syringe and markers to hold them in place and tofacilitate assembly. Bottom cover 104 preferably overlays top cover 102and is secured thereto by heat sealing or other known methods. Theentire package is preferably sterilized.

[0025]FIG. 2 illustrates another embodiment of the surgical kit of thepresent invention. Kit 200 is similar to kit 100 except for the additionof container 202 to the package. Container 202 contains a glue materialfor delivery to the leak site to seal the leak. In use, the physicianremoves the syringe 106 and container 202 from the package, and fillsthe syringe with the glue by drawing the glue into the syringe in aknown manner for delivery to the leak site. Alternatively, the containermay contain one of the components of a fibrin glue, while the syringe isfilled with an equal amount of the other component. Fibrin glue istypically equal parts fibrin and platelets.

[0026]FIG. 3 illustrates a preferred embodiment of the kit of thepresent invention. Kit 300 is similar to kit 100 except that dualchamber syringe 302 replaces single chamber syringe 106 of kit 100.Syringe 302 includes chambers 304 and 306, and contains the fluidcomponents of a fibrin glue, which gel and harden upon contact with eachother when mixed together. Chamber 304 may contain fibrin, while chamber306 may contain an equal amount of platelets. The dual chambers preventthe glue material from gelling until the fluids are delivered to theleak site. The dual chamber syringe 302 is preferably constructed with adual lumen needle 308 attached thereto, which maintains the contents ofchamber 304 separate from the contents of chamber 306 until the fluidsare adjacent the tip 310 of needle 308, so that the components of thefibrin glue do not mix until they are very close to the leak site.

[0027]FIG. 4 illustrates yet another embodiment of the kit of thepresent invention. Kit 400 is similar to kit 100 except for the additionof a second syringe 402, which is provided

[0028]FIG. 9 is a flowchart setting forth the method of the presentinvention, which utilizes the kit of the present invention. In step 900,it is determined that a patient is suffering from a post-operative rentor leak in a fluid carrying vessel organ. The present invention isparticularly suited for the repair of post-operative CSF leaks,following neurosurgical procedures, where the rent has occurred in thedura mater of the spinal cord. Pinhole-sized leaks in the dura materusually will seal themselves, while the patient is maintained in theTrendelenburg position until the rent is sealed. However, in the eventthe rent does not seal itself, after the leak is discovered in step 900,the patient is injected with a radiographic contrast agent intrathecallyat step 902, and the flow of the contrast agent is observed at step 904under CT, MRI, fluoroscopy, or the like. If the location of the leak isdetermined at step 906, a marker, such as marker 108 of kit 100described above, is affixed to the patient's body in step 908. If theleak site is not located to the satisfaction of the physician, theprocess returns to step 904.

[0029] Once the marker is placed, its location is confirmed with respectto the leak site through continued scanning at step 910. A syringe, suchas syringe 106 of kit 100 or syringe 302 of kit 300, is then providedcontaining a fibrin glue material at step 912. The needle of the syringeis inserted into the patient's body through the guide hole 710 of marker108 at step 914. The tip of the needle is positioned adjacent the rent,and its position is observed and confirmed by observation of thegraduations on the needle of the syringe and through continued scanningat step 916. Once it is determined at step 918 that the tip of theneedle is located at the site of the leak, the fibrin glue is deliveredto seal the leak at step 920. If it is determined that the needle is notproperly positioned, the process preferably for the delivery of acontrast agent for intrathecal injection into the spinal cord in thepatient's body when the kit 400 is used in procedures to repair leaks inthe dura mater of the spinal cord following a neurosurgical procedure,to assist in determining the location of the leak. The contrast agent ispreferably a radiographic agent, such as a myelographic contrast agent,but of course can be any contrast agent that is sensitive to scanningtechniques such as fluoroscopy, CT scanning, MRI, and the like. Thecontrast agent can be provided in a pre-filled syringe 402, or may beprovided separately during the repair procedure. Alternatively, thecontrast agent may be provided in a kit having a container 502 filledwith the contrast agent, along with syringe 402, syringe 106 andcontainer 202 filled with the fibrin glue material, all provided in apackage 500 as shown in FIG. 5.

[0030]FIG. 6 illustrates a further embodiment of the kit of the presentintention. Kit 600 is similar to kit 100 except for the addition ofsurgical drape 602, which can be used during the surgical repairprocedure.

[0031]FIG. 7 illustrates a preferred embodiment of the fiducial marker108 that is packaged with the kit of the present invention, and used inaccordance with the method of repairing a leak in a fluid carryingvessel or organ of the present invention. Preferably, the marker 108 isconstructed of a radiopaque plastic material and includes a centrallylocated hole 710, which is of a size that can accommodate the needle ofsyringe 106. The marker 108 is adhesive backed for securement to theskin of the patient. returns to step 916.

[0032] While the invention has been shown and described with referenceto certain preferred embodiments, it will be understood by those skilledin the art that various changes in form and detail may be made thereinwithout departing from the spirit and scope of the invention, as definedby the appended claims.

What is claimed is:
 1. A surgical kit for repairing a fluid leak ininternal fluid carrying vessels and organs, comprising: at least onesyringe having a needle; at least one container for carrying abio-compatible fluid, said fluid serving to fill a breach in an internalfluid carrying vessel or organ; at least one marker for placement on apatient's body to mark the breach in the vessel or organ, the markerserving as a needle guide for the needle of the syringe to assist inplacement of the needle adjacent the breach; and a package including atop cover and a bottom cover, said top and bottom cover forming apackage containing the at least one syringe, the at least one container,and the at least one marker.
 2. A surgical kit according to claim 1,further comprising at least one sterile surgical drape.
 3. A surgicalkit according to claim 1, wherein the bio-compatible fluid is a fibringlue material.
 4. A surgical kit according to claim 1, wherein themarker is radiopaque and includes a hole which passes through the markerto accommodate the needle of the syringe, to guide insertion of theneedle into the patient.
 5. A surgical kit according to claim 1, whereinthe syringe contains a fluid which reacts with the bio-compatiblematerial to form a fibrin glue material to fill the breach in the fluidcarrying vessel or organ.
 6. A surgical kit according to claim 1,further comprising a container for carrying a myelographic contrastagent, and a syringe having a needle for delivering the agent to thevessel or organ having the breach.
 7. A surgical kit according to claim1, wherein the at least one syringe, the at least one container and theat least one marker are sterile.
 8. A surgical kit for repairing a fluidleak in internal fluid carrying vessels and organs, comprising: asyringe having a needle and containing a fluid for filling a breach inan internal fluid carrying vessel or organ; at lest one marker forplacement on a patient's body to mark the breach in the vessel or organ,the marker serving as a needle guide for the syringe to assist inplacement of the needle adjacent the breach; and a package including atop cover and bottom cover, said top and bottom cover forming a packagecontaining the at least one syringe and the at least one marker.
 9. Asurgical kit according to claim 8, further comprising at least onesterile surgical drape.
 10. A surgical kit according to claim 8, whereinthe syringe is a dual chamber syringe.
 11. A surgical kit according toclaim 10, wherein said fluid in said syringe is a fibrin glue, and afirst chamber and a second chamber of the syringe contain the componentsof the fibrin glue.
 12. A surgical kit according to claim 11, wherein aneedle of the syringe has two lumens.
 13. A surgical kit according toclaim 8, wherein the marker includes a hole which passes through themarker to accommodate the needle of the syringe, to guide insertion ofthe needle into the patient.
 14. A surgical kit according to claim 8,further comprising an additional syringe having a needle and containinga myelographic contrast agent for delivery to the vessel or organ havingthe breach.
 15. A surgical kit according to claim 14, wherein thesyringe containing the fluid, the at least one marker, and the syringecontaining the contrast agent are sterile.
 16. A surgical kit forrepairing a fluid leak in internal fluid carrying vessels and organs,comprising: a syringe having a needle for applying a fibrin gluematerial to a location adjacent a leak in an internal fluid carryingvessel or organ; at least one marker for placement on a patient's bodyto mark the location of the leak; and a package including a top coverand a bottom cover, said top and bottom cover forming a packagecontaining the at least one syringe and the at least one marker.
 17. Asurgical kit according to claim 16, further comprising at least onesterile surgical drape.
 18. A surgical kit according to claim 16,wherein the syringe is a dual chamber syringe, a first chambercontaining platelets and a second chamber containing fibrin.
 19. Asurgical kit according to claim 18, wherein a needle of the syringe hastwo lumens.
 20. A surgical kit according to claim 16, wherein the markerincludes a hole which passes through the marker to accommodate theneedle of the syringe, to guide insertion of the needle into thepatient.
 21. A surgical kit according to claim 16, further comprising asyringe having a needle and containing a myelographic contrast agent fordelivery to the vessel or organ having the leak.
 22. A surgical kitaccording to claim 21, wherein the syringe having the fibrin glue, thatat least one marker, and the syringe having the contrast agent aresterile.
 23. A method for repairing a fluid leak in internal fluidcarrying vessels and organs, comprising the steps of: determining that aleak has occurred in a fluid carrying vessel or organ; injecting aradiographic contrast agent into the fluid carrying vessel or organ;observing flow of the contrast agent using radiographic imaging todetermine the location of the leak; placing a marker on the patient'sbody to mark the location of the leak; confirming the location of theleak with respect to the marker using radiographic imaging; providing asyringe having a needle and containing a fibrin glue material; insertingthe needle into the patient's body through the marker; confirming thelocation of the distal tip of the needle of the syringe usingradiographic imaging; and delivering the fibrin glue material to thelocation of the leak to seal the leak on the fluid carrying vessel ororgan.
 24. A method for repairing a CSF leak in the dura mater of thespinal cord, comprising the steps of: (a) determining that a leak hasoccurred; (b) determining the location of the leak; (c) placing a markeron the patient's body to mark the location of the leak; (d) providing asyringe having a needle and containing fibrin glue; (e) inserting theneedle into the patient's body through the marker to the location of theleak; and (f) delivering the fibrin glue to the location of the leak toseal the leak in the dura mater.
 25. The method of claim 24, furthercomprising the step of delivering a contrast agent to the dura mater andobserving at least steps (b), (c), (e) and (f) through scanningtechniques.